Ponderano

Researchers are evaluating trastuzumab deruxtecan T-DXd as a treatment for adult patients with advanced HER2-positive gastric or gastroesophageal junction GEJ adenocarcinoma who have previously received a trastuzumab-based regimen. This study aims to assess the real-world effectiveness of T-DXd, patient characteristics, treatment patterns, and safety in this population. It also includes data collection on patients receiving conventional therapies for exploratory comparison. This is a non-interventional observational study where patients receive T-DXd or conventional therapies as part of routine clinical care according to approved guidelines SmPC. No investigational drugs are given. The study tracks patients starting T-DXd as a second-line or later treatment and collects data on other therapies such as chemotherapy and immunotherapy used in clinical practice. Participants will be followed for up to approximately 2 years from baseline to monitor outcomes including time to next treatment, changes in treatment, physician-reported safety events, use of prophylactic treatments, and quality of life using validated questionnaires. Data on physician visits, treatment discontinuation, and safety events will also be collected to understand treatment tolerability and patient experience in a real-world setting.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse SUPC, a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

Researchers are observing women undergoing endoscopic nipple-sparing mastectomy NSM with immediate breast reconstruction, a procedure used for breast cancer treatment or prophylactic mastectomy due to hereditary risk. This study aims to collect real-world data on the feasibility, safety, sensory recovery, quality of life, and long-term oncological outcomes of this minimally invasive surgery. It focuses on adult women eligible for implant-based reconstruction, assessing surgical and cancer-related results over several years. Participants undergo endoscopic NSM through a lateral inframammary incision combining open and endoscopic techniques, with intraoperative assessments and axillary staging performed when needed. Immediate prepectoral implant-based reconstruction follows the surgery. No experimental treatments or changes to usual care are applied, as this is an observational study capturing outcomes from routine clinical practice. Throughout the study, data on clinical, surgical, pathological, and follow-up evaluations are collected, including patient questionnaires on satisfaction and quality of life. Assessments occur before surgery, during, and at multiple time points up to five years after surgery. Researchers monitor surgical complications, nipple-areola complex sensation recovery, cancer recurrence, survival, and aesthetic results. Each participant is followed for five years to evaluate long-term safety and effectiveness.

Researchers are studying patients with advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The trial compares two chemotherapy approaches after an initial treatment period continuing the current chemotherapy regimen called mFOLFIRINOX or switching to a different chemotherapy combination of gemcitabine plus nab-paclitaxel. This phase III randomized trial aims to find out which approach helps patients live longer without disease progression after three months of initial chemotherapy. Participants first receive mFOLFIRINOX chemotherapy every two weeks for about 14 weeks, with at least 4 cycles required to continue in the trial. Those whose cancer has not worsened are then randomly assigned to one of two groups. One group continues mFOLFIRINOX, which includes oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil given by infusion every two weeks. The other group switches to gemcitabine and nab-paclitaxel, given on days 1, 8, and 15 in 28-day cycles. Treatment continues until the cancer progresses, side effects become unacceptable, the participant withdraws consent, or death. During the study, participants will have regular scans to monitor their cancer and assessments to track side effects, quality of life, and treatment response. Researchers will measure overall survival up to 48 months after randomization, along with progression-free survival, time until treatment stops, and other health outcomes. The trial includes ongoing evaluations of toxicity and quality of life to understand the impact of each treatment approach on patients. Participants remain under close medical supervision throughout the study period.

This research aims to evaluate the effectiveness of hypnotic communication in reducing emotional distress such as stress, anxiety, depression, anger, and the need for help in adult patients undergoing elective coronary angiography. Emotional stress from medical procedures, especially surgical ones, can negatively affect clinical outcomes and recovery. The study will be conducted as a randomized controlled trial involving 306 adults at the Cardiology Unit of Ospedale degli Infermi in Biella, Italy. Participants will be randomly assigned to one of two groups an experimental group receiving hypnotic communication alongside standard care, and a control group receiving standard care only. Hypnotic communication, delivered by trained nurses, follows a five-phase process pre-induction, induction, core, de-induction, and closure and begins at the patients bedside before the procedure, continuing through its completion. This technique uses empathetic, suggestion-based language without formal hypnosis to help manage emotional distress. During the study, participants emotional states will be assessed before preparation for the procedure and one hour after completion using the Emotion Thermometer Tool. Pain levels will also be measured 15 and 60 minutes after the procedure, and patient satisfaction with the communication technique will be recorded in the experimental group. Data will be collected at enrollment, before intervention, during, and after the procedure, with ethical approval and informed consent obtained. The study aims to support integrating hypnotic communication into routine care to improve patient well-being during invasive procedures.

Researchers are evaluating the combination of brenetafusp IMC-F106C plus nivolumab compared to standard nivolumab regimens in people with previously untreated advanced melanoma who are HLA-A*0201-positive. This phase 3, randomized, controlled study aims to understand how these treatments perform in this specific group. The study focuses on improving progression-free survival and overall outcomes for participants with advanced melanoma. Participants are assigned to one of three groups one group receives a low dose of brenetafusp once weekly for 13 weeks, then every two weeks until Week 51, and every four weeks thereafter, along with nivolumab every four weeks another group receives a high dose of brenetafusp on the same schedule plus nivolumab the third group receives nivolumab alone or nivolumab combined with relatlimab every four weeks. The study includes a dose recommendation phase with changes made in November 2025 based on safety and efficacy data. During the study, participants undergo assessments including tumor measurements per RECIST 1.1, BRAF V600 mutation status evaluation, and performance status scoring. Researchers will monitor progression-free survival up to approximately 45 months, overall survival up to 57 months, and record adverse events, immune responses, and quality of life. The study involves regular dosing and long-term follow-up to evaluate treatment effects and safety.

Researchers are evaluating whether letrozole is more effective than standard chemotherapy for treating patients with hormone receptor positive low-grade serous epithelial ovarian carcinoma LGSCO. This phase III, open-label, randomized trial aims to see if letrozole can extend progression-free survival compared to carboplatin and paclitaxel chemotherapy. The study also explores tumor response, quality of life, pain, overall survival, safety, and genetic markers related to the disease. Participants will be randomly assigned to one of two groups one group takes letrozole tablets daily by mouth for up to 60 months or until disease progression, while the other group receives carboplatin and paclitaxel intravenously on day 1 every 21 days for 6 to 8 cycles. The treatments are compared directly to assess their effects on cancer control and patient well-being. During the study, participants will have regular assessments including tumor response evaluations, quality of life questionnaires, pain inventory, and safety monitoring according to standard criteria. Genetic profiling and circulating tumor DNA will be analyzed to understand disease characteristics. Progression-free survival will be tracked for up to 84 months, with ongoing monitoring of overall survival and adverse events. Participants will be followed closely to observe treatment effects and side effects throughout the trial period.